Corominas Júlia, Garriga Carme, Prenafeta Antoni, Moros Alexandra, Cañete Manuel, Barreiro Antonio, González-González Luis, Madrenas Laia, Güell Irina, Clotet Bonaventura, Izquierdo-Useros Nuria, Raïch-Regué Dàlia, Gallemí Marçal, Blanco Julià, Pradenas Edwards, Trinité Benjamin, G Prado Julia, Pérez-Caballero Raúl, Bernad Laia, Plana Montserrat, Esteban Ignasi, Aurrecoechea Elena, Taleb Rachel Abu, McSkimming Paula, Soriano Alex, Nava Jocelyn, Anagua Jesse Omar, Ramos Rafel, Martí Lluch Ruth, Corpes Comes Aida, Otero Romero Susana, Martínez-Gómez Xavier, Camacho-Arteaga Lina, Molto Jose, Benet Susana, Bailón Lucía, Arribas Jose R, Borobia Alberto M, Queiruga Parada Javier, Navarro-Pérez Jorge, Forner Giner Maria José, Lucas Rafael Ortí, Vázquez Jiménez María Del Mar, López Fernández María Jesús, Alvarez-Mon Melchor, Troncoso Daniel, Arana-Arri Eunate, Meijide Susana, Imaz-Ayo Natale, García Patricia Muñoz, de la Villa Sofía, Rodríguez Fernández Sara, Prat Teresa, Torroella Èlia, Ferrer Laura
HIPRA, Girona, Spain.
HIPRA, Girona, Spain.
Vaccine. 2025 Feb 15;47:126685. doi: 10.1016/j.vaccine.2024.126685. Epub 2025 Jan 13.
The HIPRA-HH-2 was a multicentre, randomized, active-controlled, double-blind, non-inferiority phase IIb clinical trial comparing the immunogenicity and safety of the PHH-1V adjuvanted recombinant vaccine as a heterologous booster against homologous booster with BNT162b2. Interim results demonstrated strong humoral and cellular immune response against the SARS-CoV-2 Wuhan-Hu-1 strain and the Beta, Delta, and Omicron BA.1 variants up to day 98 post-dosing. Here we report that these responses with PHH-1V are sustained up to 6 months, including in participants over 65 years, despite their smaller sample size. The PHH-1V booster was non-inferior in eliciting neutralizing antibodies for SARS-CoV-2 Omicron XBB.1.5 variant compared to BNT162b2 after 6 months. No severe COVID-19 cases occurred in any group, and mild cases were similar (50.4 % for PHH-1V vs. 47.8 % for BNT162b2). While both groups may have reached comparable immunity levels, these findings suggest that the PHH-1V vaccine provides long-lasting immunity against various of SARS-CoV-2 variants. ClinicalTrials.gov Identifier: NCT05142553.
HIPRA-HH-2是一项多中心、随机、活性对照、双盲、非劣效性IIb期临床试验，比较了PHH-1V佐剂重组疫苗作为异源加强针与BNT162b2同源加强针的免疫原性和安全性。中期结果表明，在给药后98天内，针对严重急性呼吸综合征冠状病毒2（SARS-CoV-2）武汉-胡-1株以及贝塔、德尔塔和奥密克戎BA.1变体，出现了强烈的体液免疫和细胞免疫反应。在此我们报告，尽管65岁以上参与者样本量较小，但使用PHH-1V的这些反应可持续长达6个月。6个月后，与BNT162b2相比，PHH-1V加强针在引发针对SARS-CoV-2奥密克戎XBB.1.5变体的中和抗体方面非劣效。任何组均未发生严重冠状病毒病2019（COVID-19）病例，轻症病例相似（PHH-1V组为50.4%，BNT162b2组为47.8%）。虽然两组可能已达到相当的免疫水平，但这些发现表明，PHH-1V疫苗可提供针对多种SARS-CoV-2变体的持久免疫力。临床试验.gov标识符：NCT05142553。
